Current status
A research program with a defined route forward
RetGuard has promising retrospective evidence and released inference artifacts. It does not yet have the device-specific, prospective, workflow, quality-system, or regulatory evidence required for clinical deployment.
| Area | Status | Meaning |
|---|---|---|
| medRxiv Version 1 | Submitted | Retrospective research manuscript submitted for screening; public DOI not yet confirmed and not peer reviewed. |
| Research inference package | Available | Versioned inference source, model weights, model cards, and checksums reported. |
| Target-device validation | Not completed | No partner camera or OCT device has been validated for a product claim. |
| Prospective clinical validation | Not completed | No prospective intent-to-screen or patient-care study. |
| Integrated clinical workflow | Not completed | No validated gradability, OOD, reporting, referral, or human-factors workflow. |
| Medical-device clearance or approval | None | RetGuard is not cleared or approved by FDA, CE-marked as a RetGuard device, or authorized for clinical use. |
| Imaging manufacturer agreement | None claimed | No camera or OCT manufacturer partnership, endorsement, or affiliation is represented. |
Translation roadmap
What must happen before a clinical product claim
1
Independent replication
Reproduce inference and key analyses with controlled artifacts and independent review.
2
Device-specific study
Validate on the intended camera or OCT platform, acquisition protocol, and target population.
3
Prospective workflow
Test gradability, OOD handling, subgroups, human factors, referral logic, and clinical utility.
4
Product governance
Define intended use, risk management, cybersecurity, QMS, regulatory strategy, and post-market plan.